Making Decisions about the Risks of Chemicals in Foods with Limited Scientific Information

ABSTRACT

On occasion, food safety managers may detect an undesirable chemical contaminant or unanticipated chemical substance in a food commodity, ingredient, or finished product, thereby warranting an assessment of the health impact of the substance at the level detected. Many times, such an assessment must be made with limited scientific information. In such situations, food safety managers must expeditiously evaluate the available data and other information and make decisions such as whether to implement a food product recall to protect public health and maintain integrity of and confidence in the food supply.

Under such circumstances, making decisions about risk can be very complicated by the interactions of a number of issues. Interpretation of scientific and public policy can cause confusion as a result of insufficient data for conducting a risk assessment, conflicting data, uncertainty stemming from toxicological issues or temporal constraints, emerging nature of the state of the science, and regulatory constraints (for example, zero tolerance). A user-friendly conceptual framework would aid food safety managers faced with making decisions about the risks of newly detected, undesired chemical substances in foods—whether naturally occurring toxins, direct or indirect food additives, substances arising through food processing, or other substances.

The Institute of Food Technologists (IFT) convened a group of experts to (1) examine the complexities that challenge timely decision-making about such substances when available scientific information is limited and (2) define and develop a workable tool to guide food safety managers in effectively and knowledgeably evaluating available scientific evidence pertinent to assessing the risk from exposure to a chemical substance to make timely decisions. This Expert Report delves into the legal U.S. underpinnings of the risk management of chemical substances in foods, international considerations, risk-benefit evaluation, importance of the food matrix to risks and benefits, risk assessment and management, and the need for a new approach to timely decision-making with limited scientific information. This report includes case studies that demonstrate (1) the various complexities and how sound decision-making with sufficient available pertinent data is reinforced as additional supportive data subsequently become available and (2) the importance of assessing and balancing consideration of risks and benefits from a whole food perspective.

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1541-4337.2009.00081.x

Introduction

Safety has no mixed connotation and, as it applies to food and health, is nonnegotiable. The food industry views food safety as its highest priority. Cooperation among producers, ingredient suppliers, food scientists, processors and other food technologists, distributors, and federal, state, and local regulatory officials is critical in ensuring the safety of the global food supply and maintaining consumer trust and confidence. There have been many efforts to improve risk assessment. Virtually all of them stress the importance of acquiring additional data. In contrast, this report deals with risk assessment on the basis of currently available and often less than adequate data. Facing the dilemma of the need to make a decision about the level of risk presented by a chemical substance associated with food, perhaps arising through the discovery of traces of a chemical, with limited or less than a desired amount of data triggers a host of questions: Is it safe? How did it get in the food? What can be done? What should be done? According to the Toxic Substances Control Act list by the U.S. Environmental Protection Agency (EPA), there are more than 75000 known chemicals in our environment, many of which may come in contact with food via soil, air, or water. The presence of chemicals such as acrylamide and polycyclic aromatic hydrocarbons (PAHs), which form upon normal food preparation and heating, may be discovered through advances in analytical methods and techniques. Other chemical substances may be intentionally added, such as direct food additives, unintentionally added, such as indirect food additives migrating from packaging components to food, naturally occurring or more deliberative, arising from accidental contamination or malicious adulteration.

Product safety is the foundation of consumer trust. However, consumer trust in the food supply can be undermined by food recalls, which may sometimes constitute the end stage of food safety assessments and decision making. An online poll of 2563 adults indicated that almost 8 in 10 adults (79%) are aware of food recalls in the United States (Harris Interactive 2007). Moreover, more than 86% of those polled mentioned at least some concern with food recalls, and 29% indicated that food recalls were a serious concern.

Food safety issues quickly become news that is rapidly disseminated to distant regions and countries at the speed of an e-mail or broadcast journalist's report. While they are the most public aspect of apparent food safety failures, food recalls is just 1 component of the complicated food safety decision-making process. Critical and challenging decisions are made prior to a recall. However, real-time information is difficult to obtain and is often limited and/or difficult to interpret. Undertaking food chemical safety assessments requires detailed knowledge of the chemistry and toxicology of the substances in question. Invariably, deficiencies or gaps in the underlying science become evident. The context of the level of exposure to a chemical substance in question also is critical in making meaningful interpretations of available information. This is particularly true when confronted with deficiencies and gaps in available scientific data. Consequently, the decision-making process in making food safety assessments can be very difficult.

This report has 3 main sections. The first section sets forth the U.S. legal framework and international institutions and measures that govern the safety of the food supply. The 2nd section deals with risk analysis—that is, how the nature and size of real or potential risks are determined or, more frequently, estimated. This section discusses in some detail ways to use the available information to best advantage, especially when that information is less complete than desirable. And the third section of the report covers how that information on the nature, size and probability of a risk can be applied in making appropriately conservative and balanced decisions. This section particularly emphasizes the need to weigh carefully information about the risk(s) of an unavoidable food component against the benefits of the food(s) in which that component is found.

For the purpose of this report, the term "risk" is defined as "the possibility of loss, injury, disadvantage, or destruction" (Gove 1993). Risk is not the reality of being deprived or in a state of disadvantage; instead, it is the threat of becoming so. Health risks are a subset of what are often called vital risks because they have a major impact on life itself. Similarly, the term "benefit" is "something that guards, aids, or promotes well-being" (Gove 1993). Secondary meanings connote something good, or producing a positive outcome. Thus, the terms "risk" and "benefit" are not opposites: Risk always and explicitly includes the element of chance; benefit does not.